Study on the Optimal Combination Pattern of the Combined Treatment of Radiotherapy and Immunotherapy for the Abscopal Effect in Non-Small Cell Lung Cancer (NSCLC) With Multiple Metastases

July 11, 2025 updated by: Jianguo Sun, Xinqiao Hospital of Chongqing

An Umbrella Trial of Combining Different Radiotherapy Fractionation Patterns With Immunotherapy for Multiple Metastases of Non-Small Cell Lung Cancer

This study aims to conduct a prospective, multicenter, umbrella clinical study to compare the abscopal effects of different radiotherapy fractionation patterns combined with Benmelstobart, and to explore an efficient and low-toxic treatment strategy for non-small cell lung cancer (NSCLC) with multiple metastases. The main objective is to explore and compare the control rates of abscopal lesions in NSCLC patients with multiple metastases when different radiotherapy fractionation patterns are combined with Benmelstobart.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

366

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400037
        • Recruiting
        • The Second Affiliated Hospital of Army Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient must meet all of the following inclusion criteria to be enrolled in this study:

    1. Non-small cell lung cancer confirmed by pathological histology.
    2. More than 3 metastatic lesions.
    3. No brain metastases or stable lesions.
    4. Negative for driver genes (including EGFR, ALK, ROS, BRAF, MET, RET).
    5. Performance status (PS) score of 0-1, with an expected survival period of more than 3 months.
    6. Age between 18 and 75 years old.
    7. Assessment by PET-CT (including FDG and FMISO, not mandatory).
    8. No contraindications to immunotherapy and radiotherapy.
    9. Signed the informed consent form.

Exclusion Criteria:

  • Patients with any of the following criteria are not eligible for enrollment in this study:

    1. Those with severe dysfunction of important vital organs (heart, liver, kidney).
    2. Those accompanied by other malignant tumors.
    3. Uncontrolled heart diseases or myocardial infarction within the past 6 months.
    4. Those with a history of mental illness.
    5. Other situations in which the researcher deems it inappropriate for the subject to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Drug: Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no progression, the patient will receive the treatment of 6-10Gy*3-6F plus Benmelstobart.
Other Names:
  • Radiotherapy
Drug: Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no progression and the largest lesion measures between 3 cm and 5 cm, the patient will receive the treatment of 3 Gy * 15 fractions plus Benmelstobart.
Other Names:
  • Radiotherapy
Drug: Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no disease progression and the largest lesion is larger than 5 cm, the patient will receive treatment with Spatial Fractionated Radiotherapy Technique (SFRT) plus Benmelstobart.
Other Names:
  • Radiotherapy
Drug: Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no disease progression, and when the largest lesion is ≤ 3 cm and the patient can maintain the radiotherapy position for 50 minutes, the patient will receive treatment with the hyperfractionated pulsed radiotherapy technique (0.5 Gy * 16 * 6 fractions) plus Benmelstobart.
Other Names:
  • Radiotherapy
Drug: Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, Benmelstobart is continued for maintenance treatment.
Experimental: Group B
Drug: Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no progression, the patient will receive the treatment of 6-10Gy*3-6F plus Benmelstobart.
Other Names:
  • Radiotherapy
Drug: Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no progression and the largest lesion measures between 3 cm and 5 cm, the patient will receive the treatment of 3 Gy * 15 fractions plus Benmelstobart.
Other Names:
  • Radiotherapy
Drug: Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no disease progression and the largest lesion is larger than 5 cm, the patient will receive treatment with Spatial Fractionated Radiotherapy Technique (SFRT) plus Benmelstobart.
Other Names:
  • Radiotherapy
Drug: Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no disease progression, and when the largest lesion is ≤ 3 cm and the patient can maintain the radiotherapy position for 50 minutes, the patient will receive treatment with the hyperfractionated pulsed radiotherapy technique (0.5 Gy * 16 * 6 fractions) plus Benmelstobart.
Other Names:
  • Radiotherapy
Drug: Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, Benmelstobart is continued for maintenance treatment.
Experimental: Group C
Drug: Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no progression, the patient will receive the treatment of 6-10Gy*3-6F plus Benmelstobart.
Other Names:
  • Radiotherapy
Drug: Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no progression and the largest lesion measures between 3 cm and 5 cm, the patient will receive the treatment of 3 Gy * 15 fractions plus Benmelstobart.
Other Names:
  • Radiotherapy
Drug: Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no disease progression and the largest lesion is larger than 5 cm, the patient will receive treatment with Spatial Fractionated Radiotherapy Technique (SFRT) plus Benmelstobart.
Other Names:
  • Radiotherapy
Drug: Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no disease progression, and when the largest lesion is ≤ 3 cm and the patient can maintain the radiotherapy position for 50 minutes, the patient will receive treatment with the hyperfractionated pulsed radiotherapy technique (0.5 Gy * 16 * 6 fractions) plus Benmelstobart.
Other Names:
  • Radiotherapy
Drug: Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, Benmelstobart is continued for maintenance treatment.
Experimental: Group D
Drug: Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no progression, the patient will receive the treatment of 6-10Gy*3-6F plus Benmelstobart.
Other Names:
  • Radiotherapy
Drug: Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no progression and the largest lesion measures between 3 cm and 5 cm, the patient will receive the treatment of 3 Gy * 15 fractions plus Benmelstobart.
Other Names:
  • Radiotherapy
Drug: Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no disease progression and the largest lesion is larger than 5 cm, the patient will receive treatment with Spatial Fractionated Radiotherapy Technique (SFRT) plus Benmelstobart.
Other Names:
  • Radiotherapy
Drug: Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no disease progression, and when the largest lesion is ≤ 3 cm and the patient can maintain the radiotherapy position for 50 minutes, the patient will receive treatment with the hyperfractionated pulsed radiotherapy technique (0.5 Gy * 16 * 6 fractions) plus Benmelstobart.
Other Names:
  • Radiotherapy
Drug: Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, Benmelstobart is continued for maintenance treatment.
Experimental: Group E
Drug: Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no progression, the patient will receive the treatment of 6-10Gy*3-6F plus Benmelstobart.
Other Names:
  • Radiotherapy
Drug: Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no progression and the largest lesion measures between 3 cm and 5 cm, the patient will receive the treatment of 3 Gy * 15 fractions plus Benmelstobart.
Other Names:
  • Radiotherapy
Drug: Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no disease progression and the largest lesion is larger than 5 cm, the patient will receive treatment with Spatial Fractionated Radiotherapy Technique (SFRT) plus Benmelstobart.
Other Names:
  • Radiotherapy
Drug: Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no disease progression, and when the largest lesion is ≤ 3 cm and the patient can maintain the radiotherapy position for 50 minutes, the patient will receive treatment with the hyperfractionated pulsed radiotherapy technique (0.5 Gy * 16 * 6 fractions) plus Benmelstobart.
Other Names:
  • Radiotherapy
Drug: Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, Benmelstobart is continued for maintenance treatment.
Experimental: Group F
Drug: Benmelstobart combined with Bevacizumab and chemotherapy
For eligible subjects who have developed resistance to EGFR-TKI, after 4 cycles of treatment with Benmelstobart combined with Bevacizumab and chemotherapy, if there is no disease progression, they will receive the treatment of 6-10Gy * 3-6 fractions plus Benmelstobart.
Other Names:
  • Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The remission rate of abscopal lesions
Time Frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to approximately 2 years
To evaluate the efficacy of Benmelstobart plus different radiotherapy fractionation modes in non-small cell lung cancer (NSCLC) patients with multiple metastases, as measured by the remission rate of abscopal lesions according to RECIST v1.1
From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to approximately 2 years
To evaluate the efficacy of Benmelstobart plus different radiotherapy fractionation modes in non-small cell lung cancer (NSCLC) patients with multiple metastases, as measured by progression-free survival rate according to RECIST v1.1
From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to approximately 2 years
OS
Time Frame: up to 5 years
To evaluate the efficacy of Benmelstobart plus different radiotherapy fractionation modes in non-small cell lung cancer (NSCLC) patients with multiple metastases, as measured by by overall survival
up to 5 years
AE
Time Frame: From date of consent informed until 60 days after the last investigational product administration. Up to approximately 2 years
The incidence of immune-related adverse events (irAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
From date of consent informed until 60 days after the last investigational product administration. Up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinqiao Hospital of Chongqing

Investigators

  • Principal Investigator: Jianguo Sun, MD, the second affiliated hospital of Army medical university, Chongqing, Chongqing 40037 Recruiting

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 9, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

April 20, 2025

First Submitted That Met QC Criteria

April 29, 2025

First Posted (Actual)

May 1, 2025

Study Record Updates

Last Update Posted (Actual)

July 14, 2025

Last Update Submitted That Met QC Criteria

July 11, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XQonc-023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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